VIV Podcast

What’s trending and timely in life sciences? Updates on Global systems and regulatory guidances

On this episode, we welcome back Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel for updates on new with global systems and regulatory guidelines.

What’s new in Quality Management System

  • For Virtual companies, what are their responsibilities in terms of quality systems?
  • What’s the new EU guidance around vendors and responsibility?
  • What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System?
  • What are the differences in protocols for QRM systems in digitally enabled and fully automated labs?
  • What’s happening with Annex 1?

More information on the topics discussed can be found at:

  1. ISO 18091:2019 Quality management systems — Guidelines for the application of ISO 9001 in local government https://www.iso.org/standard/72808.html
  2. Validation Week 2020 http://www.cbinet.com/conference/pi20083
  3. FDA Information on PQS https://www.fda.gov/media/92818/download
  4. ICH Q10 Quality Management https://www.fda.gov/media/71553/download
  5. IT and Computerized Systems Conference http://www.cbinet.com/conference/pi20045
  6. ICH guideline Q10 on pharmaceutical quality system http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf
  7. ICH guideline Q9 on quality risk management http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf

 




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